Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Insulin isophane porcine
Wockhardt UK Ltd
A10AC03
Insulin isophane porcine
100unit/1ml
Suspension for injection
Intramuscular; Subcutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 06010102; GTIN: 5012727901923
MEASURE BAR SHOULD BE 150MM AT 100% SCALE Customer Description Item Code Profile Size Min. Point Size Market Language Proof By Proof No. Date Artwork No. Pharma Code Colours Used Wockhardt UK Limited LFT HYPUR P 100U-ML VIA COMMON 104498/5 As per uploaded pdf 148 x 350mm matt.pirie-scott 2 29/10/2015 607804 120 Process Black Keylines artwork.leicester@MULTIPKG.com CLEARLY MARK ANY AMENDMENTS ON ONE PROOF AND RETURN TO MPS WARNING! We cannot accept responsibility for any errors in this proof after approval. Whilst we take extreme care at all times to ensure accuracy to our clientʼs brief, the final responsibility must be taken by our client. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT. UK English 8pt (main body) / 8pt (variables) PACKAGE LEAFLET: INFORMATION FOR THE USER HYPURIN ® PORCINE RANGE OF INSULIN INJECTION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU INJECT YOUR INSULIN. - Keep this leaflet. You may need to read it again while you are receiving your treatment. - If you have any further questions, please ask your doctor, pharmacist or diabetes nurse. - This medicine has been prescribed for you. It must not be shared with other patients. It may harm them even if their symptoms are the same as yours. IN THIS LEAFLET: 1. What Hypurin ® is and what it is used for 2. Before you receive Hypurin ® 3. How to use Hypurin ® 4. Possible side effects 5. How to store Hypurin ® 6. Further information 1. WHAT HYPURIN ® IS AND WHAT IT IS USED FOR The name of your medicine is Hypurin Porcine Insulin. Hypurin Porcine is the brand name for a range of highly purified porcine (pig) insulin injections. Hypurin Porcine Neutral is a sterile, clear solution of porcine insulin (100 international units/ml). It is short acting. Hypurin Porcine Isophane is a sterile, white suspension of porcine insulin (100 international units/ml) with protamine sulphate and zinc chloride in water. It is longer acting than Hypurin Porcine Neutral. Hypurin Porcine 30/70 Mix is a sterile, white suspension of porcin Przeczytaj cały dokument
OBJECT 1 HYPURIN PORCINE ISOPHANE VIALS - PL 29831/0121 Summary of Product Characteristics Updated 19-Jan-2016 | Wockhardt UK Ltd 1. Name of the medicinal product Hypurin® Porcine Isophane 2. Qualitative and quantitative composition Crystalline Insulin Ph Eur (Porcine) 100 IU/ml. Isophane Insulin Injection Ph Eur (Porcine) For excipients, see 6.1 3. Pharmaceutical form Suspension for injection. A white suspension 4. Clinical particulars 4.1 Therapeutic indications The treatment of insulin dependent diabetes mellitus. May be used for diabetics requiring a depot insulin of medium duration. Where a more rapid, intense onset is desirable it may be mixed with Hypurin Neutral. 4.2 Posology and method of administration Usually administered subcutaneously but where necessary it may be given intramuscularly in which case onset is more rapid and overall duration shorter. It should not be given intravenously. Onset of action occurs within 2 hours after subcutaneous injection with an overall duration of 18-24 hours. Maximum effect is exerted between 6-12 hours. 4.3 Contraindications Hypoglycaemia. Hypersensitivity to insulin or to any of the excipients. 4.4 Special warnings and precautions for use In no circumstances must Hypurin® Porcine Isophane be given intravenously. Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9). Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy. Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period'). Patients transferred to Hypurin® Porcine insulins from other commercially available preparations may require dosage adjustments. The w Przeczytaj cały dokument